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iNOS Inhibitor
Combination Therapy for Advanced Breast Cancer
Phase 2
Recruiting
Led By Polly A Niravath, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed HER2 negative MpBC and/or Triple Negative Breast Cancer (TNBC) with squamous and/or sarcomatoid elements, including osseous, chondroid, and spindle morphology
Adequate organ and marrow function as defined below: Hemoglobin ≥9.0 g/dl, Absolute neutrophil count ≥1000/μL, Platelet count ≥100,000/μL, Serum total bilirubin (TB) ≤1.5 x institutional upper limit of normal, Aspartate transaminase/alanine transaminase ≤5 x institutional ULN, Creatinine ≤1.5X the ULN or measured creatinine clearance ≥ 60 mL/min/1, Fasting blood glucose of ≤140 mg/dl and HgbA1c ≤7.0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the rp2d will be defined as the highest dose administered at which 6 patients complete treatment with experiencing <2 dlts (study completion is an average of 6 cycles, determined by diseases progression, unacceptable toxicity, physician's discretion)
Awards & highlights
Study Summary
This trial tests a combination of treatments for metastatic or locally advanced metaplastic breast cancer that hasn't responded to past treatments.
Who is the study for?
This trial is for adults with HER2 negative metastatic or advanced metaplastic breast cancer that hasn't improved after previous treatments. Participants must be able to follow the study plan, have measurable disease, and acceptable organ function. Women of childbearing age and sexually active men must use contraception. Exclusions include certain drug interactions, uncontrolled hypertension, serious heart conditions, other active cancers, severe lung disease or neuropathy, pancreatitis, blood clotting disorders on specific anticoagulants, history of severe skin reactions or untreated brain metastases.Check my eligibility
What is being tested?
The study tests the combination of alpelisib (taken orally), L-NMMA (given intravenously), and nab-paclitaxel chemotherapy in patients with a specific type of breast cancer. Treatments are given every three weeks until disease progression or unacceptable side effects occur.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea and diarrhea from alpelisib; allergic reactions to nab-paclitaxel; fatigue; changes in blood sugar levels; increased risk of infections due to lowered white blood cell counts; nerve damage causing numbness or pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is HER2 negative with specific cell types.
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Your blood, liver, and kidney function tests should be within normal range and your blood sugar levels should be controlled.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is not HER2 positive according to the latest guidelines.
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I can swallow pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the rp2d will be defined as the highest dose administered at which 6 patients complete treatment with experiencing <2 dlts (study completion is an average of 6 cycles, determined by diseases progression, unacceptable toxicity, physician's discretion)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the rp2d will be defined as the highest dose administered at which 6 patients complete treatment with experiencing <2 dlts (study completion is an average of 6 cycles, determined by diseases progression, unacceptable toxicity, physician's discretion)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Define recommended phase II dose (RP2D)
Objective response rate (ORR)
Secondary outcome measures
Analysis of responses to an iNOS inhibitor and nab-paclitaxel in combination with alpelisib.
OS of patients with HER2 negative metastatic or locally advanced MpBC
PFS of patients with HER2 negative metastatic or locally advanced MpBC
+1 moreSide effects data
From 2017 Phase 4 trial • 44 Patients • NCT0170197320%
Dizziness and paresthesias during arginine infusion
20%
Abdominal cramping and diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sitagliptin Plus Pegvisomant
Sitagliptin Plus LNMMA
Sitagliptin
Sitagliptin Plus Exendin 9-39
Trial Design
1Treatment groups
Experimental Treatment
Group I: iNOS inhibitor and nab-paclitaxel in combination with alpelisib.Experimental Treatment1 Intervention
iNOS inhibitor and nab-paclitaxel in combination with alpelisib in patients with HER2 negative, metastatic or locally advanced MpBC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-NMMA
2010
Completed Phase 4
~420
Find a Location
Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
271 Previous Clinical Trials
80,339 Total Patients Enrolled
13 Trials studying Breast Cancer
351 Patients Enrolled for Breast Cancer
Novartis PharmaceuticalsIndustry Sponsor
2,856 Previous Clinical Trials
4,197,669 Total Patients Enrolled
88 Trials studying Breast Cancer
37,812 Patients Enrolled for Breast Cancer
Polly A Niravath, MDPrincipal InvestigatorHouston Methodist Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe lung disease or lung scarring.I have moderate to severe numbness or pain in my hands or feet.My breast cancer is HER2 negative with specific cell types.I have serious heart problems or had a recent heart attack.I am not allergic to nab-paclitaxel, alpelisib, iNOS inhibitors, or aspirin.I have fully recovered from any major surgery before starting the study treatment.My breast cancer cannot be removed by surgery, has spread, and can be measured.I have stopped using strong CYP3A4 inhibitors or inducers for at least a week.I am taking medications that affect nitrate/nitrite levels.My blood pressure is under control with medication for at least 4 weeks.I am currently being treated for another cancer.I do not have HIV.I have pancreatitis.You have had a serious skin reaction called Steven Johnson's syndrome or toxic epidermal necrolysis in the past.I am on blood thinners that are not warfarin or similar.I agree to use birth control during and up to 90 days after the study, and if male, I will not donate sperm during this time.I have untreated brain metastases causing symptoms.I have issues absorbing nutrients due to past stomach or intestine surgery or disease.I have bone death in my jaw.I have an untreated stomach ulcer.I have type 1 diabetes or my type 2 diabetes is not under control (Hgb A1c >7%).Your blood, liver, and kidney function tests should be within normal range and your blood sugar levels should be controlled.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with specific cancer drugs like nab-paclitaxel or PI3K, AKT, mTOR inhibitors.My cancer is not HER2 positive according to the latest guidelines.I can swallow pills.I can take aspirin without any issues.
Research Study Groups:
This trial has the following groups:- Group 1: iNOS inhibitor and nab-paclitaxel in combination with alpelisib.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for potential participants in this research endeavor?
"According to the clinicaltrials.gov registry, this medical research is currently soliciting participants and was initially posted on December 1st 2023 with a most recent update also occurring in December of the same year."
Answered by AI
Has the FDA authorized combining iNOS inhibitor and nab-paclitaxel with alpelisib?
"Our experts at Power gave iNOS inhibitor and nab-paclitaxel in combination with alpelisib a score of 2, denoting that this is a Phase 2 trial with some preliminary evidence supporting safety but no data on efficacy."
Answered by AI
What is the maximum sample size of participants in this research trial?
"Affirmative. Clinicaltrials.gov's information reveals that this experiment is currently welcoming participants, having been initially uploaded on 12th January 2023 and last revised a month later on the same date. 36 patients are needed to be recruited from solitary institution."
Answered by AI
What are the predicted benefits of this medical experiment?
"The primary objective of this medical experiment, which will be estimated by evaluating the highest dosage in which 6 patients finish their course with less than two DLT occurences (the average duration of treatment is six cycles and can vary depending on disease progression, toxicity levels deemed unacceptable or doctor's choice) is to measure Objective Response Rate. Additional objectives include analyzing PIK3CA mutation status through tissue collection (such as E545K, E542K, H1047R/Y/L), Progression-free Survival for HER2 negative metastatic or locally advanced MpBC treated with an iNOS inhibitor and nab-pac"
Answered by AI
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